Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10315219
In Commercial Distribution

  • 00630414510293 ()
  • 00630414010137 ()
1428622

  • Calcium (Ca2+) electrode IVD
Ready Sensor™ pCO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10321857
In Commercial Distribution

  • 00630414492667 ()
5065729

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ pO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10321856
In Commercial Distribution

  • 00630414492650 ()
5065575

  • Blood oxygen electrode IVD
Reference Electrode Refill. An in vitro diagnostic device for use on the RAPIDLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324388
In Commercial Distribution

  • 00630414492643 ()
6451843

  • Ion selective electrode (ISE) reference solution IVD, reagent
Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324386
In Commercial Distribution

  • 00630414492636 ()
6449458

  • Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDLab® 1200 Series CO-ox Sample Chamber for in vitro diagnostics use.
Siemens Healthcare Diagnostics Inc.
10324165
In Commercial Distribution

  • 00630414492629 ()
6324604

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLab® 1200 Systems Wash Cartridge, for in vitro diagnostic use with RAPIDLab® 1200 series systems
Siemens Healthcare Diagnostics Inc.
10319817
In Commercial Distribution

  • 00630414492612 ()
3913056

  • Multiple blood gas analyte IVD, calibrator
RAPIDLab® 1200 Systems Reagent Cartridge for in vitro diagnostics use with the RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10319811
In Commercial Distribution

  • 00630414492605 ()
3909458

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions.
Epocal Inc
11413475
In Commercial Distribution

  • 00630414606095 ()
16266

  • Metabolic profile clinical chemistry analyser IVD
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
Ready Sensor™ pH Biosensor for use on the RapidLab® 248/348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10312556
In Commercial Distribution

  • 00630414112145 ()
  • 00630414010106 ()
476267

  • Blood pH electrode
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions.
Epocal Inc
11413524
In Commercial Distribution

  • 00630414606460 ()
11413524

  • Metabolic profile clinical chemistry analyser IVD
The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.
Siemens Healthcare Diagnostics Inc.
11416751
In Commercial Distribution

  • 00630414286143 ()
11416751

  • Blood gas/haemoximetry analyser IVD, point-of-care
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445010
In Commercial Distribution

  • 08426950807810 ()
00055445010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430010
In Commercial Distribution

  • 08426950807759 ()
00055430010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415010
In Commercial Distribution

  • 08426950807698 ()
00055415010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407510
In Commercial Distribution

  • 08426950807636 ()
00055407510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360010
In Commercial Distribution

  • 08426950807599 ()
00055360010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445011
In Commercial Distribution

  • 08426950807827 ()
00055445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430011
In Commercial Distribution

  • 08426950807766 ()
00055430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415011
In Commercial Distribution

  • 08426950807704 ()
00055415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407511
In Commercial Distribution

  • 08426950807643 ()
00055407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360011
In Commercial Distribution

  • 08426950807605 ()
00055360011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Prime Reference Cartridge
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480420433 ()
42043

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Prime Sensor Card CCS Comp
NOVA BIOMEDICAL CORPORATION
Prime CCS Comp
In Commercial Distribution

  • 10385480420331 ()
  • 00385480420334 ()
42033

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Sensor Card CCS
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480420324 ()
  • 00385480420327 ()
42032

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Prime CCS w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480536660 ()
  • 10385480536667 ()
53666

  • Blood gas analyser IVD, point-of-care
Prime CCS w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CSS
In Commercial Distribution

  • 00385480536561 ()
  • 10385480536568 ()
53656

  • Blood gas analyser IVD, point-of-care
Remanufactured PRIME CCS Comp Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480534208 ()
  • 10385480534205 ()
53420

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime Probe S Line 100 ul
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480525824 ()
52582

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Pump Harness
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524841 ()
52484

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Capillary Tube 150 uL with Balanced Heparin 250 per vial
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480567268 ()
  • 00385489567269 ()
56726

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Capillary Tube 230 uL with Balanced Heparin 250 per vial
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480567251 ()
  • 00385489567252 ()
56725

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Sensor Card CCS Comp (High Volume)
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480552643 ()
  • 00385480552646 ()
55264

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Sensor Card CCS (High Volume)
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 10385480552636 ()
  • 00385480552639 ()
55263

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Remanufactured Prime CCS Comp w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480536677 ()
  • 10385480536674 ()
53667

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime CCS Comp w/ Scanner Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480536578 ()
  • 10385480536575 ()
53657

  • Blood gas/haemoximetry analyser IVD, point-of-care
Remanufacture PRIME CCS Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480534185 ()
  • 10385480534182 ()
53418

  • Co-oximetry analyser IVD, point-of-care
Stat Profile Prime Calibrator Flush Fixture
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480528658 ()
52865

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime CCS Comp Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS COMP
In Commercial Distribution

  • 00385480528573 ()
  • 10385480528570 ()
52857

  • Blood gas/haemoximetry analyser IVD, point-of-care
Prime CCS Analyzer
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480528566 ()
  • 10385480528563 ()
52856

  • Blood gas analyser IVD, point-of-care
Prime Safety Sample Port 5 Pk
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480526692 ()
  • 00385489526693 ()
52669

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Tubing L1 L2 L3
NOVA BIOMEDICAL CORPORATION
Prime ABG/CCS
In Commercial Distribution

  • 00385480526173 ()
52617

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Prime Tubing L1 L2 L3
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480526166 ()
52616

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system
S1720 Calibration Solution 1 200 mL, for ABL7XX.
Radiometer Medical ApS
944-064
Not in Commercial Distribution

  • 05700699440648 ()
944-064

  • Multiple blood gas analyte IVD, calibrator
Rinse Solution S4970 REF 944-057 600mL
Radiometer Medical ApS
944-057
In Commercial Distribution

  • 05700699440570 ()
944-057

  • Wash/cleaning solution IVD, automated/semi-automated system
S1730 Calibration Solution 2 200 mL, for ABL7XX
Radiometer Medical ApS
944-025
Not in Commercial Distribution

  • 05700699440259 ()
944-025

  • Multiple blood gas analyte IVD, calibrator
S1720 Calibration Solution 1 200 mL, for ABL7XX
Radiometer Medical ApS
944-024
Not in Commercial Distribution

  • 05700699440242 ()
944-024

  • Multiple blood gas analyte IVD, calibrator
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
Radiometer Medical ApS
944-021
In Commercial Distribution

  • 05700699440211 ()
  • 55700699440216 ()
944-021

  • Multiple blood gas analyte IVD, calibrator
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